Welcome
Support Centre
31 October 2014 
ISRCTN Register - International Standard Randomized Controlled Trial Number
Trial registration
Unique identification scheme
International databases
home  |   my details  |   ISRCTN Register  |   mRCT  |   links  |   information  |   news
Find trials
ISRCTN Register
tips on searching

Registration
New application
Updating record

Information
introduction
governing board
ISRCTN FAQs
data set
letter of agreement
request information
guidance notes
statistics

[ Print-friendly version ]
A multicentre, randomised, double-blind, placebo-controlled trial to evaluate intravenous infusion of salbutamol versus saline for 28-day mortality in patients with acute respiratory distress syndrome
ISRCTN ISRCTN38366450
DOI 10.1186/ISRCTN38366450
ClinicalTrials.gov identifier
EudraCT number
Public title A multicentre, randomised, double-blind, placebo-controlled trial to evaluate intravenous infusion of salbutamol versus saline for 28-day mortality in patients with acute respiratory distress syndrome
Scientific title
Acronym BALTI-2
Serial number at source Version 2
Study hypothesis In patients with acute respiratory distress syndrome (ARDS), treatment with intravenous salbutamol will reduce 28-day mortality
Lay summary Not provided at time of registration
Ethics approval West Midlands Multicentre Research Ethics Committee, approval pending as of 01/05/2006
Study design Randomised, double-blind, placebo-controlled trial
Countries of recruitment United Kingdom
Disease/condition/study domain Acute respiratory distress syndrome
Participants - inclusion criteria On day 1 following intensive care unit (ICU) admission, the primary caring ICU clinician should consider all adult patients (age ≥18 years) with severe hypoxaemic respiratory failure (PaO2/FiO2) ≤26.7 kPa to be eligible for inclusion in the trial
Participants - exclusion criteria 1. Pregnancy
2. Cardiogenic pulmonary oedema (confirmed by medical history and chest x-ray)
3. Severe obstructive airway disease requiring nebulised or intravenous (IV) beta 2-agonists
4. Treatment with beta 2-blockers ≤48 hours
5. Brain stem death
6. Treatment withdrawal ≤24 hours, which indicates any interventions (including a trial) would be considered inappropriate
7. Refusing consent or patients in whom relatives refuse assent
8. Enrolled in another interventional clinical trial in the last 28 days
Anticipated start date 01/08/2006
Anticipated end date 01/09/2007
Status of trial Completed
Patient information material Not available in web format, please use the contact details below to request a patient information sheet
Target number of participants 100
Interventions Salbutamol or placebo will be administered through a dedicated intravenous line for seven days
Primary outcome measure(s) Mortality 28 days after randomisation
Secondary outcome measure(s) 1. Number of ventilator-free days
2. Mortality at (first) discharge from ICU
3. Mortality at discharge from hospital
4. Mortality at 12 months post randomisation
5. ICU length of stay
6. Hospital length of stay
7. Disability and quality of life at 12 months after randomisation
Sources of funding Intensive Care Society
Trial website
Publications 1. 2011 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/21554679
2. 2012 results in: http://www.ncbi.nlm.nih.gov/pubmed/22166903
3. 2013 results in: http://www.ncbi.nlm.nih.gov/pubmed/24028755
Contact name Prof  Fang  Gao
  Address Adult Intensive Care Unit
Birmingham Heartlands Hospital
Bordesley Green East
  City/town Birmingham
  Zip/Postcode B9 5SS
  Country United Kingdom
Sponsor Heart of England NHS Foundation Trust (UK)
  Address Birmingham Heartlands Hospital
Bordesley Green East
  City/town Birmingham
  Zip/Postcode B9 5SS
  Country United Kingdom
Date applied 14/04/2006
Last edited 16/09/2013
Date ISRCTN assigned 07/07/2006
Submit your trial protocol
Submit to Trials journal
Follow us on Twitter
© 2014 ISRCTN unless otherwise stated.